Good vs Great: A Conversation on Clinical Trial Supply

Mark Woolf, Chief Operating Officer at COREX, on biosimilars, direct-to-patient models, and what really separates a reliable clinical trial supply partner from an exceptional one.

Clinical trial supply rarely makes headlines, but it is where a lot of trials quietly succeed or fail. A modern clinical trial supply chain spans multiple geographies, customs regimes, and temperature requirements at once, and the clinical trial supply services wrapped around it are what keep a study moving. We sat down with Mark Woolf to talk through three of the pressures shaping the field right now.

Biosimilar development is booming. How is that affecting competition for innovator reference products?

Demand for reference products has increased substantially, and that is creating real supply constraints, higher acquisition costs, and longer sourcing timelines. The practical consequence is that sponsors increasingly have to secure inventory earlier than they used to, and lean on partners who specialise in sourcing clinical trial supplies to guarantee continuity right through development.

Good clinical trial drug supply management means you can no longer assume the reference product will simply be there when you need it. You plan for scarcity, and wherever possible you secure comparators directly from manufacturers rather than through a chain of middlemen.

What is the reality of supporting decentralised or direct-to-patient models, from a supply perspective?
Decentralised trials are wonderful for patient convenience and recruitment, but they add a great deal of logistical complexity. It means more planning, not less. You are dealing with direct-to-patient shipping, local regulations, temperature control, patient privacy under GDPR, and real-time inventory visibility, all while maintaining compliance and product integrity.

In practice, that is where clinical trial supply logistics earns its keep: validated shippers, customs brokerage across the EU, CIS, and Asia, and clinical trial distribution that can go to a site or straight to a patient's door.

This is something we do every day through our Managed Access Programmes. We ship from anywhere in Europe to the rest of the world, to CIS and former-CIS nations like Georgia, Kazakhstan, Armenia, and Moldova, and places like North Macedonia. For each one we have to have the Importer of Record in place, the relevant permits, GDPR compliance, temperature control, and an understanding of the local regulations, which differ in every country.

The volumes are very low, because these are products for specific named patients. They do not go into a centralised depot; they go directly to a clinical site. That raises the stakes on getting it right first time. The product, whether it is an investigational medicinal product (IMP) or a comparator, has to be correctly labelled and ready to use, because these sites do not have the ability to fix things if a shipment arrives incorrectly.

So what actually separates a good clinical trial supply partner from a great one?
A good partner reliably executes shipments and manages inventory. That is the baseline, and it matters. But a great partner combines that operational excellence with proactive problem-solving, regulatory expertise, genuine global reach, risk-mitigation strategies, and end-to-end supply chain visibility, and crucially, the ability to adapt quickly when trial requirements change.

That last point is where it really shows. Requirements change constantly: an increase in volume, more clinical sites, a longer country list. A great partner can move very quickly and absorb those changes, handle the Importer of Record and importation, manage the IMP and wider clinical trial material supply, select the right courier, and then communicate all of it back to the sponsor, because the sponsor has their own tasks too: labelling, shipping documentation, and the rest. It is a two-way relationship. We keep the client up to date on what they need to provide us, and we stay on top of our couriers and vendors so the product gets from A to B as smoothly and quickly as possible.

Can you give a real example of that adaptability?
Earlier this year we ran a Managed Access Programme into Armenia, managed by one of our team, for a single patient, a single shipment that only needs to repeat every three months to keep the clinical site supplied. The challenge was that we have no legal entity in Armenia, so getting an Importer of Record there was difficult. The sponsor had no entity or partner there either, so we had to find all of it.

And Armenia was effectively dropped on us as a quick fix: a patient appeared who was eligible for the trial, and under the sponsor's ethical obligations they had to be added. So we had to react very, very quickly, engage the Ministry of Health, line up couriers through our vendor management and transport teams, and bring a lot of stakeholders together to get the drug product from its source to that one clinical site. That is what adaptability looks like in practice: a new country coming onto a study with very little notice, and the supply chain simply has to deliver.

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